At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts, including our Jeffrey Kahn, explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries

At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts, including our Jeffrey Kahn, explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries

Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics, called the current regulatory framework for gene editing “robust,” but cautioned the committee on several ethical challenges that regulators will face as the use of these technologies moves forward.

First, Kahn said that regulators will need to find a way to manage “indication creep” for gene therapies, as once those technologies reach the market it may be difficult to ensure they are used in the intended manner.

Kahn also said gene editing that would introduce heritable changes raise serious ethical concerns. “We will need very strict oversight if that’s ever to go forward,” he said, pointing to recommendations from the National Academies of Science as a model for future guidelines.

The government doesn’t want to stand in the way of autonomous vehicles. That’s the biggest message to emerge from the Trump administration’s newly updated guidelines for the nascent robo-car industry.

The guidelines—and they are very much guidelines, not rules or regulations, which is a message frequently reiterated in the document—build on a set of 15 points published this time last year by the Obama administration. But transportation secretary Elaine Chao has decided to thin those out to make life easier for tech companies and automakers.

FISHERS, Ind. — Fragments of bone and cartilage arced across the operating room as Dr. R. Michael Meneghini drilled into the knee of his first patient at a hospital here at dawn. Within an hour, the 66-year-old woman had a replacement joint made of titanium and cobalt chrome, and she was sent home the next day.

But the Obama administration was watching over her caregivers’ shoulders. If, over three months, her medical costs exceeded a target amount set by President Obama’s health regulators in Washington, Dr. Meneghini’s employer, Indiana University Health, stood to lose money.

Such efforts to squeeze spending out of the nation’s health system may well remain as Mr. Obama exits the West Wing and Donald J. Trump takes his seat in the Oval Office. The Affordable Care Act is in extreme peril, and Mr. Obama will meet with congressional Democrats at the Capitol on Wednesday to try to devise a strategy that can stave off the quick-strike repeal of the health law that Republicans plan for the opening months of the Trump administration.

As the ancient Chinese proverb says, from crisis comes opportunity. That is certainly true for Garen Wintemute, a leading gun-violence researcher and emergency room doctor who finds “teaching moments” in the grief-filled days and weeks following mass shootings in America

As the ancient Chinese proverb says, from crisis comes opportunity. That is certainly true for Garen Wintemute, a leading gun-violence researcher and emergency room doctor who finds “teaching moments” in the grief-filled days and weeks following mass shootings in America

He is using a window of opportunity recently opened by the mass shooting in Orlando, Fla., to bring attention to the issue.

Wintemute, once named a “hero of medicine” by Time magazine, has led the Violence Prevention Research Program at the University of California, Davis Medical Center for 25 years. Twenty years ago, the federal Centers for Disease Control and Prevention abruptly stopped funding Wintemute’s program. He has since put up $1.3 million of his own money to keep it running.

Wintemute is one of the nation’s most prominent gun violence experts. He studies the problem from a public health perspective, using empirical research, and then proposes potential solutions based on his findings.

The rule is the first of its kind in the United States, and although it applies only within the tiny state, it is having national impact.

Most major food and beverage companies have already added language to their labels to meet the new rule, rather than deal with the logistical hassle of having separate labels for different states. Campbell Soup was the first big company to say it would label all of its products, and General Mills, ConAgra, Mars and Kellogg’s followed.

But not all the same products will definitely be on shelves. Coca-Cola said some of its less popular brands may not be available in Vermont right away. (Coca-Cola, Diet Coke and Coke Zero will be available.) And the trade association representing the major food companies has remained staunchly opposed to Vermont’s regulation.

The false hope of right-to-try laws. Alison Bateman-House & Arthur Caplan write: “Are right-to-try laws a good idea? In 2014, they began appearing throughout the United States, first in Colorado and now in 23 states, with several more considering passing versions of this popular legislation.”

The false hope of right-to-try laws. Alison Bateman-House & Arthur Caplan write: “Are right-to-try laws a good idea? In 2014, they began appearing throughout the United States, first in Colorado and now in 23 states, with several more considering passing versions of this popular legislation.”

Are right-to-try laws a good idea? In 2014, they began appearing throughout the United States, first in Colorado and now in 23 states, with several more considering passing versions of this popular legislation.

At first glance these bills may seem worth enacting. Right-to-try (RTT) laws promise terminally ill patients that they can obtain experimental drugs or medical devices in their quests to save or extend their lives. These investigational medical products are still in development and have not yet met the requirements set by the Food and Drug Administration (FDA) in order to be approved for sale or use in the United States. In some cases, the products are still being tested and patient access would primarily be by enrolling in a clinical trial – something terminally ill people may be too unwell to do. Less commonly, the products have completed clinical testing and are waiting for an approval verdict from the FDA. In either case, RTT laws are about providing terminally ill patients access to unapproved drugs or devices.

Of course we want to help people who are dying, so legislation that would give patients access to possible treatments would appear laudable. However, this conclusion is based on several assumptions. The first is that RTT legislation grants a patient a new right of some kind. Assumption two is that state legislation has jurisdiction over when a patient may access an investigational medical product. Assumption three is that use of an investigational medical product will help, or at least do no harm, to a patient. And the fourth assumption is that use of the experimental medical product is intended to benefit the patient. We argue that none of these assumptions are universally valid. Even more troubling, RTT legislation may harm the very patients that those backing the legislation claim to be helping.

How can this be? The answer lies in what the legislation, both passed laws and pending bills, actually says. RTT legislation is quite similar in content from state to state, as it is all based upon a model bill put out by the Goldwater Institute, a libertarian think tank based in Arizona. According to the language of this model bill:
“A manufacturer of an investigational drug…may make available and an eligible patient may request the manufacturer’s investigational drug…under this act. This act does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.”(1)

And there’s not much they can do about it. Brandon Coats, a 34-year-old quadriplegic whose doctor prescribed medical marijuana to stop his muscle spasms, recently lost his wrongful termination suit against Dish Network, which fired him in 2010 for testing positive for THC. Medical and recreational marijuana are both legal in Colorado, but it’s against Dish’s national company policy

And there’s not much they can do about it. Brandon Coats, a 34-year-old quadriplegic whose doctor prescribed medical marijuana to stop his muscle spasms, recently lost his wrongful termination suit against Dish Network, which fired him in 2010 for testing positive for THC. Medical and recreational marijuana are both legal in Colorado, but it’s against Dish’s national company policy

In another case, the employee argued that being allowed to use medical marijuana should be considered a “reasonable accommodation” for someone with a disability, but the court ruled that using an illegal drug was not “reasonable,” Krebel Chang said.

If there were clear evidence that medical marijuana was the only effective treatment for Coats’ muscle spasms, he would at least have ethics on his side, said Brendan Saloner, an assistant professor of health policy and management at the Johns Hopkins Berman Institute of Bioethics.

“Marijuana has clinical benefits but those benefits are not totally understood right now. That’s where cases like this get murky,” said Saloner, adding that he could not weigh in from a legal perspective.